An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

Official Title ICMJE

Breast Cancer Care (BRECC) Registry - Development of a Breast Cancer Registry to Determine the Magnitude of Breast Cancer and Current Clinical Care Patterns in Kenya

Brief Summary

This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Newly diagnosed breast cancer patients

Condition ICMJE

Breast Cancer

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

410

Estimated Completion Date

October 2018

Estimated Primary Completion Date

October 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer

No previous interventional therapy for breast cancer

Ability to provide written informed consent as per GCP and local regulations

Exclusion Criteria:

Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment

Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse